US Food and Drug Administration FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs

April 15, 2025 — Washington, D.C.
In a landmark move poised to reshape the future of drug development, the U.S. Food and Drug Administration (FDA) announced on Wednesday a new initiative to phase out its long-standing requirement for animal testing in the evaluation of monoclonal antibody therapies and other drugs. The shift will embrace cutting-edge, human-relevant technologies that promise to enhance safety assessments, speed up drug approvals, and reduce the ethical burden of animal use.

FDA Commissioner Dr. Martin A. Makary called the initiative a “paradigm shift in drug evaluation,” highlighting how the agency plans to leverage artificial intelligence, organ-on-a-chip systems, and real-world human data to replace or minimize animal experimentation.

“For too long, drug manufacturers have performed additional animal testing of drugs that have data in broad human use internationally,” said Dr. Makary. “This initiative marks a win-win for public health and ethics.”

What’s Changing?

The FDA’s new roadmap, released alongside the announcement, outlines a modernized framework for assessing drug safety and efficacy—one that heavily incorporates New Approach Methodologies (NAMs). These include:

• AI-based simulations that model how a drug behaves in the human body and predict possible toxicities.

• Human cell-based models and organoids—miniature lab-grown versions of organs—that can show how real human tissue would respond to a new therapy.

• Global human safety data, enabling the FDA to rely on existing clinical evidence from other countries with comparable regulatory standards, reducing the need for repetitive animal studies.

The agency is beginning immediate implementation of the plan for investigational new drug (IND) applications. Drug developers are now encouraged to submit NAMs data in place of traditional animal studies. Additionally, the FDA will launch a pilot program this year for monoclonal antibody developers, offering the opportunity to proceed with primarily non-animal testing strategies under close agency consultation.

Why It Matters

This shift is especially significant for the booming field of monoclonal antibodies—lab-created molecules that mimic the immune system to fight diseases ranging from cancer to autoimmune disorders.

Key anticipated benefits include:

• Faster drug development timelines, helping new treatments reach patients sooner.

• Reduced research and development costs, which could ultimately lower drug prices.

• Improved safety outcomes, thanks to more predictive human-based testing systems.

• Significant reductions in animal use, potentially sparing thousands of animals annually.

The move aligns with mounting pressure from both Congress and the scientific community to modernize the nation’s drug evaluation processes and adopt more humane, science-based alternatives to animal testing.

Building the Future of Testing

The FDA’s effort is part of a broader collaboration across federal agencies, including the National Institutes of Health, the Department of Veterans Affairs, and the National Toxicology Program. Together, they will coordinate through the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) to validate and promote the adoption of NAMs.

A public workshop is planned later this year to solicit feedback from industry, researchers, and advocacy groups on the implementation of the roadmap.

“Patients deserve treatments that are not only effective but evaluated using the most accurate tools we have,” said Makary. “And those tools are no longer cages and test tubes—but chips, code, and human cells.”

This initiative marks a pivotal moment in biomedical innovation and regulatory reform—ushering in a new era where ethics and efficacy go hand in hand.

Source – FDA